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 / Spring 2006 / Issue 42(originally published by Booz & Company)


Research Meets Practice

Using common standards and an open source approach (one that encourages participants to join in designing and expanding the system), caBIG links data, research tools, scientists, and organizations in a virtual research environment. The goal is to create a voluntary forum in which the sharing of data produces research synergies and speeds the process of discovery. The most significant challenges are not technical, but cultural. For scientists to achieve the vision, former competitors will need to collaborate.

Today, research teams sequester precious data as they race to publish their findings in peer-reviewed journals. Those who publish first, and most often, are rewarded with grants, promotions, and tenure. Although competition certainly encourages productivity, the stagnation in discovery of new chemical compounds suggests that the benefits of isolated research do not outweigh the costs. Therefore, in addition to making information sharing technically feasible, the caBIG designers are seeking to prompt a dramatic cultural change in the cancer research community to make collaboration more likely. This will not occur through goodwill alone; incentives such as grant awards, academic promotion, and tenure are needed to break down the “information silos” that separated those researchers in Seattle and Baltimore.

Now consider the case of William B., the patient in the second story, who is grappling with brain cancer — and a communication breakdown as well, though he doesn’t know it. The inability to match William in Buffalo with Dr. Kelly in Cleveland is both tragic and expensive. Currently, it costs an average of more than $900 million to bring a new drug to market, with an average clinical trial budget of $162 million. Approximately 16 percent of the clinical trial budget goes to patient enrollment: finding people like William whose diseases qualify them for participation in the experiments. Pharmaceutical company executives have ranked patient enrollment as the process with the greatest opportunity for improvement in their clinical research enterprise. This perspective is supported by the CenterWatch “State of the Clinical Trials Industry” report for 2005, which estimates that more than half of the delays in clinical trials can be attributed to patient recruitment problems.

Why is it so hard to find patients for trials? Because physicians don’t have the information they need for referrals. Only one-third of patients learn about clinical trials from their primary-care or specialty-care physicians. That’s hardly surprising, given the results of another CenterWatch study — “Will Physicians Refer Their Patients into Clinical Trials?” (March 2004) — in which 58 percent of physicians said they don’t refer their patients because they lack information on the treatment or trial, followed by 30 percent who said they didn’t have enough time to learn about and evaluate the trial, and 28 percent who said they were unsure where to refer their patients.

Intelligent Health-Care Records
Imagine a different scenario for William. Instead of a paper chart, his physician uses an “intelligent” electronic health record (EHR) that links to a research infrastructure network such as caBIG. Smart applications scan William’s health data and note that he is 53 years old, that his liver and kidney functions are normal, and that his CAT scan reveals a brain mass measuring 4 centimeters in diameter. The biopsy report in the EHR confirms the diagnosis of glioma. The computer then scans a list of current clinical trials in NCI’s databases, whittles it down to those relevant to glioma, and further examines inclusion and exclusion criteria for those trials — factors such as tumor size, duration of previous treatment, age, and kidney and liver function. The EHR recognizes that William may be eligible for at least three clinical trials that are still recruiting patients, including Dr. Kelly’s. A message appears on the computer screen in William’s physician’s office, stating William may be eligible for clinical trials at one or more NCI-designated cancer research centers. William’s physician clicks on one of the links, and a user-friendly recruitment process has begun.

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